LSI SOLUTIONS® · 4 months ago
Quality Analyst (Quality Control) (Evening 2:30pm - 11:00pm)
Victor, NY, US
Full-time
Onsite
Entry, Mid, Senior Level
$21/hr - $27/hr
2+ years expLSI SOLUTIONS® is a dynamic medical device company located in Victor, New York, dedicated to advancing minimally invasive surgical instruments. The Quality Analyst role involves performing quality control inspections, conducting audits, and ensuring compliance with quality standards within a cleanroom environment.
Health CareManufacturingMedical
Responsibilities
Process paperwork accurately and neatly
Work in Cleanroom Environment
Maintain consistent quality and workmanship
Conduct detailed records review
Search and locate documents in Grand Avenue Software (GAS)
Perform all process steps within 2 product families
Properly transact materials in ERP system
Conduct inspection and in-process audit of material status throughout product realization
Ensure enforcement of good documentation practices within Device History Records
Originate Nonconformance reports
Segregate and control non-conforming product
Perform Level I functions efficiently and effectively without continuous supervision
Understand and support Cleanroom and Quality System processes
Participate in the creation of metrics reports with Quality Engineers
Maintain databases to support metrics reporting
Participate in developing standard work instructions
Assist in internal audits, as necessary
Suggest process and system continuous improvements
Participate in Continuous Improvement Teams
Support Quality Engineers in project completion
Perform PM activities (i.e. bioburden, environmental monitoring)
Coordinate Nonconformance reports
Assist in supervision of staff and monitoring productivity
Assist in training of new employees and coaching existing employees
Assist team members. Be helpful and encouraging
All other duties as assigned
Qualification
Required
Process paperwork accurately and neatly
Work in Cleanroom Environment
Maintain consistent quality and workmanship
Conduct detailed records review
Search and locate documents in Grand Avenue Software (GAS)
Perform all process steps within 2 product families
Properly transact materials in ERP system
Conduct inspection and in-process audit of material status throughout product realization
Ensure enforcement of good documentation practices within Device History Records
Originate Nonconformance reports
Segregate and control non-conforming product
Perform Level I functions efficiently and effectively without continuous supervision
Understand and support Cleanroom and Quality System processes
Participate in the creation of metrics reports with Quality Engineers
Maintain databases to support metrics reporting
Participate in developing standard work instructions
Assist in internal audits, as necessary
Suggest process and system continuous improvements
Participate in Continuous Improvement Teams
Support Quality Engineers in project completion
Perform PM activities (i.e. bioburden, environmental monitoring)
Coordinate Nonconformance reports
Assist in supervision of staff and monitoring productivity
Assist in training of new employees and coaching existing employees
Assist team members. Be helpful and encouraging
Excellent verbal and written communication skills with various levels of management and coworkers
Demonstrated ability to follow instructions, both written and verbal
Able to communicate effectively with cross-functional teams in a manner that supports internal and external customers alike
Ability to exercise independent judgement as well as work alongside team members
Demonstrated proficiency using Microsoft Office applications including Excel
Working knowledge of ERP systems and other electronic databases
Maintain good and cooperative relationships with colleagues involved in other aspects of the process or operations in order to promote strong teamwork
Attention to detail, technical aptitude, and process-oriented troubleshooting skills necessary
Able to create metrics, maintain databases, analyze and recognize trends and inconsistencies
Experience with continuous improvement efforts of systems and processes
Familiarity assisting with quality audits
Demonstrated ability to assist in the supervision, training, and coaching of others
High School Diploma or equivalent and 2 years of demonstrated success in a highly regulated manufacturing environment acceptable in lieu of Associate degree
Preferred
Associate degree in a technical discipline preferred
ASQ CQPA or CQA Certification preferred
Familiarity with GMPs, Quality Standards, and Regulatory Compliance is highly desired
Quality Control Inspection, Line Audit and Documentation Review preferred
Benefits
Bonus Plan
401(k) plan with company match
Tuition Assistance
Employee Assistance Program (EAP)
Product Discounts
15 Paid Holidays
PTO
Sick Time
Medical, Vision and Dental effective first day of employment
Employee Referral Bonuses
Company
LSI SOLUTIONS®
We at LSI Solutions integrate patient‑focused values, precision manufacturing, and deep surgical collaboration to redefine what's possible in minimally invasive surgery.
501-1000 employees
H1B Sponsorship
LSI SOLUTIONS® has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (4)
2023 (1)
2022 (1)
2021 (1)
Funding
Current Stage
Late StageLeadership Team
J
Jude S. Sauer
President & CEO
Recent News
2025-04-02
Company data provided by crunchbase